Kornimate/medical-research-clean huggingface dataset:
side effects of autologous mesenchymal stem cell transplantation in ankle joint osteoartritis

Conditions: Osteoarthritis

Summary: ankle osteoarthritis is a joint condition which results from damage and loss of the cartilage in a joint. treatment options for ankle osteoarthritis are usually aimed at controlling pain and limiting motion that provokes the pain. nonsurgical treatment approaches are tried first. if unsuccessful, surgical options are considered. stem cell therapy is one of the therapeutic options that can repair the damaged cartilage. bone marrow derived mesenchymal stem cells have showed the capacity of bone and cartilage regeneration.

in this clinical study the investigators aim to investigate the safety of intra-articular injection of cultured autologous bone marrow derived mesenchymal stem cells (bm-mscs) to the ankle joint in patients with severe ankle osteoarthritis. patients will undergo bone marrow aspiration and will receive cultured bm-mscs one month later. patients will be assessed clinically with scoring system (fao, vas, womac) preoperatively as well as 2 and 6 months postoperative to measure pain reduction and joint function improvement. paraclinical studies (x-ray and mri) will be performed before and 6 months after treatment.

Eligibility criteria:
inclusion criteria: * osteoarthritis diagnosed by mri * end stage osteoarthritis candidate for total ankle replacement exclusion criteria: * pregnancy or lactating * positive tests for hiv, hcv, hbv * active neurologic disorder * end organ damage * uncontrolled endocrine disorder

Keywords: side effect mesenchymal stem cell ankle osteoarthritis
fluconazole pharmacokinetics in infants

Conditions: Fungal Infection

Summary: the purpose of this study is to determine the pharmacokinetics of fluconazole in infants and evaluate the dose exposure relationship of current fluconazole dosing in infants who are receiving fluconazole for the prevention or treatment of systemic fungal infections.

systemic fungal infections in neonates are associated with high morbidity and mortality. the increasing use of intravenous central catheters, parenteral nutrition, and antibiotics in neonatal intensive care units has contributed not only to improved survival but also to the increasing incidence of fungal sepsis particularly in preterm infants. decreasing fungal colonization can decrease the risk of systemic fungal infection. fluconazole is a potent antifungal agent in the triazole family. fluconazole has been shown to reduce the risk of fungal colonization and systemic infection however we do not have sufficient pharmacokinetic information in neonates to support dosing guidelines. in this study, we will perform a population pharmacokinetic study in neonates receiving fluconazole as standard of care. fluconazole levels will be measured using a liquid chromatography/tandem mass spectroscopy (lc/ms/ms) assay from very small quantities of blood appropriate for neonates. pharmacokinetic data obtained in this study will support appropriate dosing of fluconazole in neonates and provide information regarding drug metabolism in neonates.

Eligibility criteria:
inclusion criteria: 1. infant born \>23 weeks gestational age with postnatal age \<120 days 2. due to receive fluconazole therapy for clinical care 3. permission from attending neonatologist 4. informed consent of parent or legal guardian

Keywords: fungal infection sepsis pharmacokinetics
pronation in covid-19 patients undergoing non invasive respiratory support

Conditions: Covid19

Summary: pronation seems feasible and effective in improving blood oxygenation in patients with covid-19 pneumonia. data are lacking on the effects of pronation on clinical outcome in this subset of patients.


Eligibility criteria:
inclusion criteria: inclusion criteria * patients aged ≥18 and \< 80 years old * acute respiratory failure exclusion criteria: * endotracheal intubation performed within the first 24 hours from admission, * ceiling of escalation of intensive care * do not intubate order as expressed by patient willing or upon clinical judgement * missing core data at medical record analysis (clinical features at baseline, pronation information, type and time of ventilatory support required, mortality, need for tracheostomy, length of respiratory intensive care unit and hospital stay).

Keywords: spontaneous breathing awake pronation covid-19 respiratory failure
serratus anterior plane block versus erector spinae plane block with dexmedetomidine added to bupivacaine for ultrasound-guided pain management after mastectomy

Conditions: Serratus Anterior Plane Block; Erector Spinae Plane Block; Dexmedetomidine; Bupivacaine; Ultrasound; Pain Management; Mastectomy

Summary: this study aimed to compare the serratus plane block versus the erector spinae plane block with dexmedetomidine added to bupivacaine for acute pain management after breast surgeries.

approximately 40-60% of breast surgery patients endure severe acute postoperative pain, with over 10% of patients experiencing severe pain for six to twelve months (post-mastectomy pain syndrome). dexmedetomidine has analgesic properties, which could be related to the stimulation of α2 adrenoceptors, inhibition of nerve conduction through c and aδ fibers, and the local release of encephalin. serratus plane block (spb) is an effective approach for breast surgery analgesia due to its simplicity of delivery, minimal risk of adverse effects, and ability to provide significant pain relief. the erector spinae plane block (espb) is one of the emerging regional techniques for managing postoperative pain. espb can be given unilaterally during modified radical mastectomy.

Eligibility criteria:
inclusion criteria: * women aged \>20 years. * patient's approval. * american society of anesthesiologists (asa) physical status i-ii. * patients underwent breast surgeries. exclusion criteria: * known allergy to local anesthetics, opioids, or dexmedetomidine medications. * advanced heart block, ventricular dysfunction. * skin infection at the site of injection. * pre-existing chronic pain. * coagulopathies, significant liver or renal insufficiency.
efficacy & long-term safety comparison study of nk-104-cr & livalo® ir with primary hyperlipidemia or mixed dyslipidemia

Conditions: Hyperlipidemia; Dyslipidemia

Summary: the purpose of this study is to demonstrate the superior efficacy of nk-104-cr 8 mg daily compared to livalo® ir 4 mg daily on fasting serum low-density lipoprotein cholesterol (ldl-c) reduction and to evaluate the comparative safety of nk-104-cr 8 mg daily to livalo® ir 4 mg daily after long-term treatment


Eligibility criteria:
inclusion criteria: * male and female patients with primary hyperlipidemia or mixed dyslipidemia * patients for whom lipid-lowering therapy is indicated according to ncep atpiii * patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 4 weeks before randomization and throughout study participation exclusion criteria: * homozygous familial hypercholesterolemia; * any conditions which may cause secondary dyslipidemia. * newly diagnosed or poorly controlled diabetes mellitus as defined by hba1c \>9%
efficacy and safety of namilumab for moderate-to-severe axial spondyloarthritis

Conditions: Axial Spondyloarthritis

Summary: the study will assess the effect of namilumab, a gm-csf inhibitor, on the clinical response in subjects with axial spondyloarthritis. subjects will receive treatment with either namilumab or placebo.

a phase 2a proof-of-concept, randomised, double-blind, placebo-controlled study to evaluate the safety/tolerability and efficacy of 4 subcutaneous injections of namilumab (150 mg) given over 10 weeks in subjects with moderate-to-severely active axial spondyloarthritis including those previously exposed to anti- tnf therapy (namaste study).

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 75 years of age. * diagnosis of axspa by an appropriately qualified physician and classified using asas criteria ≥ 3 months prior to baseline. * bath ankylosing spondylitis disease activity index score ≥ 4 and spinal pain score ≥ 40, at screening and baseline. * mri evidence of active axspa ≤ 6 (ideally ≤ 3) months prior to randomisation using asas criteria. * stable nsaid use prior to study entry. * stable use of mtx, sulfasalazine or leflunomide prior to study entry. * stable oral corticosteroid dose prior to study entry. * capable of giving signed informed consent. * inadequately responded to or experienced intolerance to previous treatment with an anti-tnf agent (some subjects). exclusion criteria: * current diagnosis of axspa with a basdai \> 4 but no evidence of inflammation on mri. * discontinued biologic therapy \< 8 weeks prior to baseline. * previous or current use of oral corticosteroid as defined in protocol. * received intra-articular or i.v. corticosteroids prior to or during screening. * received anti-il-17a or anti-il-12/23 therapy. * received cyclosporine, tacrolimus or mycophenolate mofetil prior to baseline. * previously received stem cell transplantation. * infection(s) requiring treatment with i.v. anti-infectives or oral anti-infectives prior to baseline. * abnormal screening laboratory and other analyses. * receipt of any live vaccine within 2 weeks prior to randomisation, or will require live vaccination during study participation. * evidence of current or prior dysplasia or history of malignancy. * has had any uncontrolled and/or clinically significant illness, hospitalisation, or any surgical procedure requiring general anaesthesia prior to screening, or any planned surgical procedure within 6 months after randomisation. * known current or previous interstitial lung disease. * positive pregnancy test at screening (serum) or baseline (urine). * female subjects who are breastfeeding or considering becoming pregnant during the study. * considered by the investigator to be an unsuitable candidate for the study. * received any investigational agent or procedure within 30 days or 5 half-lives prior to baseline. * related to or a dependent of the site staff, or a member of the site staff.
decide-cv using ai

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to identify digital biomarkers associated with type 2 diabetes mellitus (t2dm) by combining sensor data from a wrist-worn wearable and clinical data. this will be done by recruiting patients with and without diabetes within the cardio-metabolic clinics a the muhc. consented patients will be provided with a hop technologies (hop) watch in this project across two observation periods. the watch-hop platform facilitates the development of predictive algorithms built with data collected in a clinical setting or at home in a passive (sensors) and active (self-assessments) way. data from the watch-hop will be analyzed using machine learning strategies to determine associations with clinical measures of t2dm.

the epidemic of type 2 diabetes mellitus (t2dm) continues to increase. sensor technologies and artificial intelligence present us with an opportunity to identify patients suffering from t2dm and to optimize their treatment. specifically, our primary objective is to identify digital biomarkers associated with t2dm by combining sensor data from a wrist-worn wearable and clinical data.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. able to follow-up with study protocol schedule 3. life expectancy \> 1 year 4. case group only a. hba1c \>= 6.5% or is diagnosed with t2dm exclusion criteria: 1. age \> 18 years 2. able to follow-up with study protocol schedule 3. life expectancy \> 1 year 4. case group only a. hba1c \>= 6.5% or is diagnosed with t2dm

Keywords: type 2 diabetes artificial intelligence wearable technology cardiovascular complications digital biomarker
high-protein diets and diabetes

Conditions: Type 2 Diabetes

Summary: high-protein (hp) diets are popular and evidence indicates they are more likely to be adhered to and produce more sustained weight loss, particularly under ad libitum conditions. they also improve glucose control and so may be helpful for treatment of type 2 diabetes (t2d), particularly in the short-term, possibly via an improvement in insulin secretion. indeed, hp diets may be uniquely effective at promoting insulin secretion in t2d, but further research is needed to understand why hp. thus, there is an urgent need to determine how hp diets affect t2d pathophysiology of insulin secretion and action using direct measures of β-cell dysfunction and insulin sensitivity. it is also imperative to know how the type of protein (animal vs. non-animal) affects insulin secretion in order to ultimately obtain an environmentally and economically sustainable hp diet that can improve glucose control and t2d pathophysiology in the long-term as well as providing patients with a greater choice for dietary management of t2d.


Eligibility criteria:
inclusion criteria: * aged 40-70 y * body-mass index of 27-45 kg/m2 * diagnosed with t2d with their most recent hba1c value greater than 6.0% (\>43 mmol/mol) and receiving dietary advice and/or antidiabetic medication (metformin, dpp-4 inhibitors only). * males and females exclusion criteria: * habitual dietary intake of \ 1.2 g/kg/day protein (determined from dietary history interview given at screening) * current use of insulin * hba1c of 12% or more (≥108 mmol/mol) * weight loss of more than 5 kg within the past 6 months * a recent estimated glomerular filtration rate (egfr) of less than 30 ml/min, * heart failure, * participation in another clinical research trial, substance abuse, known cancer, myocardial infarction within the previous 6 months, current treatment with anti-obesity drugs, pregnancy or consideration of pregnancy, and hospital admission for depression or use of antipsychotic drugs.
expression of lc3-i, lc3-ii & beclin 1 in vitiligo

Conditions: Autophagy

Summary: the exact mechanism of impairment of autophagy in vitiligo has not yet been determined.


Eligibility criteria:
inclusion criteria: * • patients with non-segmental vitiligo whether active or stable. * age above 12 years. * both sexes. exclusion criteria: * • patients should not use any topical or systemic treatment at least 6 weeks before inclusion into the study. * patients having other autoimmune disease, heart disease, liver disease, kidney disease, neurological disorder, cancer, active infection or any chronic disease. * pregnancy or breast feeding for female patients.
biomarkers of iron homeostasis and responses to cystic fibrosis pulmonary exacerbation (cfpe) treatment

Conditions: Cystic Fibrosis

Summary: the goal of this study is to identify chemical compounds in the blood and sputum (i.e., biomarkers) that are associated with objective measurements of health status in patients with cystic fibrosis (cf). this study builds upon observations that blood levels of hepcidin-25, a protein that regulates how the body uses and stores iron, vary during cf pulmonary exacerbation (cfpe).


Eligibility criteria:
inclusion criteria (required at screening visit): * diagnosis of cf confirmed by history of positive chloride sweat test and/or cftr mutation analysis; * history of consistent sputum production on most occasions; * fev1% greater than or equal to 75% of best measurement in previous 6 months; * 1 or more hospitalizations for cfpe treatment with intravenous antibiotics within the previous year; * absence of cfpe (i.e., akron pulmonary exacerbation score \<5); * not admitted to hospital within the previous 3 weeks; * body weight greater than or equal to 75% of best measurement in previous 6 months; * provision of signed informed-consent to study protocol; * 18\ 65 exclusion criteria: * women who are pregnant or lactating; * subject does not meet inclusion criteria; * recent and/or persistent visible blood in sputum (hemoptysis); * rescue use of oral antibiotics within the previous 3 weeks, defined as antibiotic use for health deterioration rather than chronic suppression

Keywords: iron hepcidin-25 pulmonary exacerbation interleukin-6
association of intravenous ketamine with thoracic epidural analgesia: effects on pain and respiratory function following thoracotomy.

Conditions: Thoracotomy

Summary: thoracotomy for lung resection is deemed painful. ketamine is now a renewed interest in preventing acute postoperative pain. a previous study performed in the service testing the association ketamine/morphine versus morphine pca, postoperative, for patients who do not benefit from postoperative epidural thoracic surgery, has demonstrated a reduction of postoperative pain associated with a reduction of nocturnal arterial desaturation following surgery when ketamine was added to morphine.

in this prospective double blind randomized study, intravenous administration of an analgesic dose of ketamine was started since the induction of general anesthesia and continued during the first 48 postoperative hours in association with epidural analgesia.

Eligibility criteria:
inclusion criteria: * subject between 18 and 85 years * subject of both sexes * subject operated in the service of thoracic surgery of a lobectomy by thoracotomie lateral or postlaterale subject * subject operated in settled surgery exclusion criteria: * against indication in the epidural insanity, * confusionnel, patient psychotic * treatment in the long price by medicine which can interfere on the pain (morphine, antidepressants, psychotropic treatment)
amplatzer duct occluder ii additional sizes

Conditions: Patent Ductus Arteriosus

Summary: the ado ii as study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ado ii as device in patients with a patent ductus arteriosus (pda). subjects will be implanted with the ado ii as device using a transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance. to account for subject dropout, up to 50 subjects will be enrolled in this clinical investigation. up to an additional 150 subjects may be enrolled under continued access. the clinical investigation will be conducted at up to 10 centers in the united states. subjects participating in this clinical investigation will be followed for 3 years. the expected duration of enrollment is 18 months. the total duration of the clinical investigation is expected to be 4.5 years.


Eligibility criteria:
inclusion criteria: * diagnosis of a pda * pda ≤ 4mm in diameter * pda ≥ 3mm in length * subject (or legally authorized representative) is willing to comply with all pre-procedure, post-procedure, and follow-up testing requirements and provides consent to participate in the clinical study note: this study is enrolling children and all local laws and governing irb requirements will be followed for obtaining informed consent exclusion criteria: * weight \< 700 grams at time of the procedure * age \< 3 days at time of procedure * coarctation of the aorta * left pulmonary artery stenosis * cardiac output that is dependent on right to left shunt through the patent ductus arteriosus due to pulmonary hypertension * intracardiac thrombus * active infection requiring treatment at the time of implant * female subjects of child bearing potential are either pregnant or desire to become pregnant within six months post implant * other disease process likely to limit survival to less than six (6) months * participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints

Keywords: pda sjm-cip-10171 ado ii as ide cap
dexmedetpmidine versus ketamine for postoperative sore throat in sinus surgery

Conditions: Sore Throat

Summary: the aim of this randomized clinical trial is to evaluate the impact of dexmedetomidine versus ketamine soaked pharyngeal packing on postoperative sore throat in functional endoscopic sinus surgery (fess).

a written informed consent was taken from the patients.patients will be randomly assigned to three groups of 40 subjects each; dexmedetomidine or ketamine or saline soaked pharyngeal packs were situated under direct vision. throat packs made of gauze with a length of 20 cm and a width of 10 cm (folded transverse four times) and medications were diluted with 20 ml normal saline. the packings were placed by the surgeon blinded to the study groups. 1-dexmedetomidine group: 75 µg dexmedetomidine soaked pharyngeal pack (group d) putted in the posterior pharyngeal wall after induction of anesthesia and \& endotracheal tube (ett). 2-ketamine group: 50 mg ketamine soaked pharyngeal pack (group k) putted in the posterior pharyngeal wall after induction of anesthesia and ett. 3-control group: 20 ml 0.9% saline soaked pharyngeal pack (group c) putted in the posterior pharyngeal wall after induction of anesthesia and ett.

Eligibility criteria:
inclusion criteria: * adults of both sex with american society of anesthesiologists (asa) physical status i-ii * elective functional endoscopic sinus surgery (fess) with endotracheal intubation. exclusion criteria: * a history of preoperative sore throat. * upper respiratory tract illness * potentially difficult airway * patients with history of neck, respiratory or digestive tract pathology * chronic smokers * using steroid within the last 48 hour * pregnant women
use of a disk of amniotic membrane (visio-amtrix) in postoperative care after pkr

Conditions: Myopia; Astigmatism; Hypermetropia

Summary: the purpose of this open controlled multicenter trial is to assess the impact of use of an amniotic membrane on post pkr recovery.

photorefractive keratectomy (prk) and laser-assisted in situ keratomileusis (lasik) are two of the most widely used techniques of laser vision correction. however, one of the major disadvantages of the prk technique is the pain experienced during 1 to 3 days after intervention. preliminary data on a limited number of patients tend to show a reduction of pain, tearing and discomfort in patients for whom a amniotic membrane was used under a therapeutic lens.

Eligibility criteria:
inclusion criteria: * male or female, aged 18 to 80 years. * patient undergoing bilateral prk procedure for myopia, astigmatism or hypermetropia with technique chosen for one of the following reasons: thin cornea, irregular cornea, suspected keratoconus, practice of combat or contact sports, professional activity at risk of direct impact. * patient understanding french language. * patient who received the study information and provided written consent to participation in the study. * patient who is a member or a beneficiary of a national health insurance plan. exclusion criteria: * pregnant woman. * patient with a contraindication to prk. * diabetic patient. * patient allergic to oxybuprocaine and / or tetracaine eye drops, to local anesthetics or to fluorescein. * monophthalmic patient. * person deprived of liberty by a judicial or administrative decision. * adult subjected to a legal protection measure or unable to express his / her consent.

Keywords: photorefractive keratectomy (prk)